Cvac Aspiration System
2 catalogue numbers from CVC127020R-1, listed by Calyxo, Inc., United States, under Ureteroscope And Accessories, Flexible/Rigid. 21 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (3), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
Showing 12 of 21. All 21 manufacturers in China registered for Ureteroscope And Accessories, Flexible/Rigid
Record
| Listed by | Calyxo, Inc., United States |
|---|---|
| FDA product code | FGB |
| Device type | Ureteroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K233472 |
| Record published | 2025-09-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CVC127020R-1 | In distribution | |
| CVC127020-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 36 |
| SemiFlex Scope | Maxiflex, LLC | 33 |
| E-Line | Richard Wolf Gmbh | 28 |
| Olympus | Olympus Winter & IBE Gmbh | 28 |
| Uscope | Zhuhai Pusen Medical Technology Co., Ltd. | 23 |
| WiScope® | OTU Medical Inc | 16 |
| Redpine | Guangzhou RED Pine Medical Instrument Co., Ltd. | 16 |
| LithoVue | Boston Scientific Corporation | 15 |
| Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 14 |
| Dornier MedTech | Dornier Medtech America, Inc. | 12 |
| Innovex | Shanghai AnQing Medical Instrument Co., Ltd. | 12 |
| Single Use Video Ureteroscope Direct In-Scope Suction | Zhuhai Pusen Medical Technology Co., Ltd. | 12 |
Showing 12 of 75. All products under Ureteroscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260013 | 2026-03-06 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Calyxo, Inc. | 510(k) number | 2025-02-19 | Class I | Device Design | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid infl | 11,246 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.